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Kaksoistehtävä vs. Monikomponenttinen liikunta laitossenioreilla (DT-Fall)

maanantai 2. marraskuuta 2026 päivittänyt: Filipe Fernandes Rodrigues, Instituto Politécnico de Leiria

Kaksitehtäväisen vs. monikomponenttisen liikuntaohjelman vaikutukset vanhuskotien asukkaiden kaatumisen pelkoon ja kaatumisriskiin: satunnaistettu kontrolloitu tutkimus

The aging global population faces a major public health challenge regarding the growing number of older adults in long-term care facilities. Institutionalized older adults exhibit high rates of sedentary behavior, accelerating physiological decline (such as sarcopenia, diminished muscle strength, and impaired balance) and increasing fall risk. Beyond biomechanical risks, the fear of falling acts as a psychological barrier, creating a negative spiral of frailty where a lack of confidence leads to activity restriction. This further reduces functional capacity and paradoxically increases the actual fall risk. Addressing fall risk requires interventions targeting both the physical mechanisms of balance and the psychological mechanisms of self-efficacy.

Current WHO guidelines emphasize multicomponent physical activity (combining balance, strength, and aerobic training) to prevent falls. However, traditional programs may not fully address the cognitive-motor interference of real-world falls, which often occur during complex, divided-attention tasks. Institutionalized older adults often struggle to allocate attentional resources efficiently. This study posits that breaking the spiral of inactivity requires stimulating the complex demands of daily living. The investigators hypothesize that a Dual-Task Exercise Program, integrating cognitive challenges (e.g., executive function tasks, memory recall) into a multicomponent routine, will provide superior benefits compared to a Multicomponent Exercise Program alone. By training cognitive functions to process mental stimuli while maintaining motor control, the goal is to improve physical and cognitive capabilities and enhance participants' confidence.

This randomized controlled trial aims to compare the effects of these two modalities on physical fall risk and psychological fear of falling. Conducted in a nursing home for over 12 weeks, participants will be randomly assigned to either the Control Group (Multicomponent Training: physical strength and balance) or the Experimental Group (Dual-Task Training: physical protocol with simultaneous cognitive stimulation).

Tutkimuksen yleiskatsaus

Yksityiskohtainen kuvaus

Ageing is a universal biological process. However, the trajectory of physical and cognitive decline varies significantly across individuals based on their lifestyle and environment. Literature consistently demonstrates that older adults residing in long-term care institutions (nursing homes) represent a particularly vulnerable demographic compared to those living in the community. While community-dwelling older adults often maintain a baseline level of physical activity through household chores, social interactions, and recreational tasks, institutionalized older adults frequently face an environment characterized by sedentarism and a lack of autonomy. This environmental physical deprivation in institutional settings leads not only to physical deconditioning (loss of strength, loss of balance, and reduced mobility) but also to a lack of cognitive stimulation. The absence of complex daily challenges means that these individuals rarely engage the neuro-motor pathways required to manage simultaneous tasks. Consequently, institutionalized older adults are at a disproportionately high risk of adverse health outcomes, most notably falls.

Falls are not merely biomechanical events caused by muscle weakness; they are deeply intertwined with psychological factors. Recent systematic reviews highlight fear of falling as a critical health concern that affects a vast majority of institutionalized older adults, regardless of whether they have a history of falling. Fear of falling acts as a psychological barrier that triggers a negative spiral of frailty, specifically, the fear leads to self-imposed activity restriction, which further degrades physical fitness (i.e., strength and balance), thereby paradoxically increasing the actual risk of future falls. Breaking this cycle is imperative. The literature suggests that interventions must address not only the physical capacity to move but also the confidence to move safely. While physical activity is widely recognized as a protective factor, reducing fall risk and promoting independence, the specific type of physical activity that best addresses the psychological aspect of fear of falling remains a subject of investigation.

International guidelines, such as those from the World Health Organization and Cochrane reviews, advocate for multicomponent exercise programs by combining resistance, balance, and aerobic training, as the most effective strategy for fall prevention. These programs, typically prescribed at moderate intensities, have proven effective in improving pure physical parameters like muscle strength and static balance. However, a critical gap exists between clinical improvements and real-world applicability. Standard multicomponent exercise is often performed in controlled environments where the individual focuses exclusively on the motor task (i.e., single tasking). Yet, in daily life, falls rarely occur when an individual is solely focused on walking. Instead, falls predominantly happen during complex, multi-task scenarios, such as walking while talking or carrying objects, navigating obstacles, or processing environmental cues. This discrepancy suggests that traditional multicomponent training may lack ecological validity. It strengthens the muscles but may not sufficiently train the brain to allocate attentional resources efficiently during movement, leaving the older adult vulnerable when distracted.

The Cognitive-Motor Interference theory posits that when older adults with cognitive deficits attempt to perform a motor task and a cognitive task simultaneously, performance in one or both domains deteriorates. This dual-task cost is a strong predictor of falls. Therefore, to effectively reduce fall risk and, crucially, the fear of falling, an intervention must simulate these complex demands. This leads to the hypothesis that dual-task training, the integration of simultaneous cognitive challenges (e.g., verbal fluency, arithmetic calculations, memory recall) into physical exercise, may offer superior benefits to multicomponent training alone. By forcing the central nervous system to manage competing attentional demands, dual-task training aims to improve neuroplasticity and executive function alongside physical conditioning.

The primary aim of this investigation is to determine whether increasing the complexity of the training stimulus (Dual-Task) yields greater benefits than the standard physical stimulus (Multicomponent) in institutionalized older adults. Specifically, this study seeks to understand if adding a cognitive load to a standard exercise protocol is a key ingredient required to significantly reduce fear of falling and improve functional mobility in this specific population. Rather than focusing solely on the volume or intensity of exercise, as emphasized in general guidelines, this research focuses on the specificity of the training type. If dual-task training proves more effective, it suggests that fall prevention strategies in nursing homes should move beyond simple repetitive movements and embrace physical and cognitive training. The findings will support healthcare professionals in tailoring interventions that are not only physically strengthening but also cognitively engaging, ultimately promoting a more robust and confident functional independence among the oldest old.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

54

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

    • Leiria District
      • Alcobaça, Leiria District, Portugali, 2460-009
        • Santa Casa da Misericórdia de Alcobaça

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

65 vuotta ja vanhemmat (Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  • Aged 65 years or older.
  • Resident in the institution (nursing home) for at least 6 months.
  • Autonomous ambulation capacity (independent walking ability, with or without walking aids like canes or walkers).
  • Medical clearance/approval to participate in physical exercise.
  • Ability to understand verbal instructions and communicate.
  • Absence of severe cognitive impairment that prevents understanding of the tasks.

Exclusion Criteria:

  • Uncontrolled cardiovascular or metabolic conditions (e.g., severe heart failure, unstable angina, recent myocardial infarction in the last month).
  • Severe musculoskeletal, visual, or auditory impairments that preclude participation in the exercise program.
  • Diagnosis of severe dementia or other neurological conditions that prevent following the protocol instructions.
  • Absence from more than 5 consecutive sessions or attendance of less than 75% of the total sessions.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Yksittäinen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: Multicomponent Exercise Group

Participants in this group will perform a standard multicomponent exercise program.

The program consists of 45-60 minute sessions, twice a week for 12 weeks. It includes resistance training (using free weights, elastic bands, and body weight), static and dynamic balance training, and aerobic walking exercises. Intensity is moderate, adjusted to individual tolerance using the Borg Scale.

Kokeellinen: Dual-Task Exercise Group

Participants in this group will perform the multicomponent protocol with added cognitive demands.

Participants perform the exact same physical exercises as the control group (same duration, frequency, and intensity), but with simultaneous cognitive tasks designed to induce cognitive-motor interference. Tasks include verbal fluency (naming animals/colors), arithmetic calculations (subtraction), and memory recall while performing motor movements.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change in Fear of Falling
Aikaikkuna: Baseline (Week 0) and Post-Intervention (Week 13).

Assessed using the Falls Efficacy Scale International (FES-I). This self-report questionnaire assesses the level of concern about falling during 16 social and physical activities inside and outside the home. Total scores range from 16 (no concern) to 64 (extreme concern).

Baseline (Week 0) and Post-Intervention (Week 13).

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change in Functional Mobility and Fall Risk
Aikaikkuna: Baseline (Week 0) and Post-Intervention (Week 13).

Assessed using the Timed Up and Go (TUG) test. Measures the time (in seconds) required to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Lower times indicate better mobility and reduced fall risk.

Baseline (Week 0) and Post-Intervention (Week 13).
Change in Physical Performance
Aikaikkuna: Baseline (Week 0) and Post-Intervention (Week 13).

Assessed using the Short Physical Performance Battery (SPPB). A composite score evaluating three domains: balance (side-by-side, semi-tandem, tandem stands), gait speed (4 meters), and chair stand ability (5 repetitions). Total scores range from a minimum of 0 to a maximum of 12. Higher scores indicate a better outcome (better physical function).

Baseline (Week 0) and Post-Intervention (Week 13).
Exercise Adherence (Attendance Rate)
Aikaikkuna: Through study completion (up to Week 12).

Measures the frequency of participation in the assigned exercise program. It will be recorded as the total number of sessions attended by each participant divided by the total number of scheduled sessions (24 sessions), expressed as a percentage. This variable assesses the feasibility and acceptance of the training frequency.

Through study completion (up to Week 12).

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Maanantai 10. marraskuuta 2025

Ensisijainen valmistuminen (Todellinen)

Perjantai 27. helmikuuta 2026

Opintojen valmistuminen (Todellinen)

Perjantai 27. helmikuuta 2026

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 17. helmikuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 17. helmikuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Maanantai 23. helmikuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 4. marraskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 2. marraskuuta 2026

Viimeksi vahvistettu

Perjantai 1. toukokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muut tutkimustunnusnumerot

  • CE/IPLEIRIA/88/2025

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-jaon aikakehys

Data will be available beginning 6 months and ending 5 years following article publication.

IPD-jaon käyttöoikeuskriteerit

Researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator (filipe.rodrigues@ipleiria.pt). To gain access, data requestors will need to sign a data access agreement.

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • ICF

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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